FDA.report

Diagnostix™

Primary DI
00634782884277
Brand
Diagnostix™
Company
AMERICAN DIAGNOSTIC CORP
Model
922-01
Catalog number
922-01
Device description
DIAGNOSTIX Desk Merc,Manometer only, INSP
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DXQBlood Pressure Cuff

Product Code Classifications

CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00634782884277PackageGS16In Commercial Distribution
00634782082901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782884277006347828842776347828842770634782884277
00634782082901006347820829016347820829010634782082901

GMDN Terms

TermDefinition
Mercury manual sphygmomanometerA device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, a mercury manometer, and tubing. The mercury manometer consists of a reservoir containing mercury (Hg) and a graduated column in which the mercury rises and falls in response to pressure in the cuff. The manometer may be mounted to a wall or placed on a table and is considered the gold standard for measuring blood pressure because it remains calibrated; blood pressure measurement is taken in conjunction with a stethoscope.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-4 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags

DUNS number
108999095
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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